CMC-Pharma Product Group Director

Overview

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Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The Pharma Product Group Director will be fully responsible for providing CMC leadership and overseeing project management for both commercial and pipeline small molecule or hybrid products. This role serves as a key leader within the S&T PPG group and supports CMC Leads across PDS&T, independently driving CMC initiatives.

Responsibilities

• Independently lead complex and/or hybrid cross-functional PDS&T product teams. Represent the CMC team and/or PDS&T in interface with PDS&T leadership, other Operations functions, other AbbVie functions and external partners. Participate in or lead/coordinate Governance efforts such as Product Performance Teams or gate reviews.
• Develop and maintain comprehensive project plans, budgets, timelines and strategy; technical projects at all stages of development are included, from phase II through commercial. Independently develops and executes the control strategy for Pipeline products.
• Ensure sound, proactive technical ownership of the product, process and methods by the CMC team; facilitate the identification and resolution of technical issues and prioritization of efforts with strategic understanding of the impact on Operations.
• Understand and present technical information regarding drug product and drug substance manufacturing processes and methods, process development/history and process characterization to senior management and regulatory agencies.
• Prepare and review submissions through registration of the product as well as post-approval life-cycle management. Serve as a peer/management reviewer for regulatory submissions.
• Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team and collaborate with multidisciplinary team including R&D, RA, and Operations (MES, QA, sites, Supply Chain, purchasing, etc.)
• Manage multiple, complex or hybrid projects at various stages of development, commercialization and commercial manufacturing.
• Develop new and less experienced CMC leads through sponsor/mentor relationships, and mentor experienced CMC Leads in growth/development assignments.
• Identify and promote best practices among PDS&T CMC leads.
• Establish and foster partnerships with key customers and counterpart functions to and facilitate effective collaboration.

Qualifications

• Bachelor s Degree with 16+ years of relevant experience (CMC, small molecule manufacturing/development); Masters Degree with 14+ years of relevant experience; PhD Degree with at least 12+ years of relevant experience.
• CMC development experience through IND and/or NDA/MAA. Experience leading multiple CMC project teams through IND and NDA/MAA preferred.
• Technical understanding and experience with small molecule products manufacturing, development, quality and analytics is required.
• Knowledge and experience with FDA and global regulatory requirements for CMC issues is required. Ability to influence internal and external experts on CMC regulatory issues, independently.
• Demonstrated excellence in writing, presentation, and overall communication.
• Demonstrated excellence in leading CMC project teams.
• Demonstrated ability to provide strategic direction for work groups, departments, etc.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law. The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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Seniority level: Director

Employment type: Full-time

Job function: Product Management and Marketing

Industries: Internet News

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